Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa

Who is this study for? Patients with early stage hidradenitis suppurativa
What treatments are being studied? Ruxolitinib
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity. Investigators aim to: * Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment. * Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Male or female subjects age 12 years or older

• Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules, nodules, and/or abscess formation, single or multiple, with or without sinus tracts;

• Subjects must have a diagnosis of HS for at least 3 months (90 days) prior to Baseline;

• Active HS lesions must be present in at least one distinct anatomic area;

• Subject must have at least 3 total inflammatory lesions at the Baseline visit;

• Subjects who had surgery in the treatment area, should be at least 3 months status post the procedure (this applies to deroofing/marsupialization or excision, not incision \& drainage)

• Subject has a negative TB screening assessment (including a PPD test and/or Quantiferon-TB Gold test equivalent) OR for patients with treated latent TB or negative chest x-ray (CXR posterior-anterior \[PA\] and lateral view within prior 90 days) at Screening with documentation of treated latent tuberculosis (90 days of treatment).

• Medications can be continued if they have been at a stable dose for the requisite duration and the dose is not increased during the study period:

‣ Biologic medication (such as TNF, IL-12/23 or IL-17 inhibitors): Up to 30% of enrolled participants will be allowed to remain on a concurrent biologic at stable dosage if treated with a stable dose and frequency for 6 months or longer;

⁃ Oral antibiotic must be a stable dose and frequency for 28 days or longer;

⁃ Hormone-based therapy (birth control pills or spironolactone) must be a stable dose and frequency for 4 months or longer;

⁃ Oral retinoids must be on a stable dose and frequency for 90 days or longer;

⁃ Other topical therapy must be discontinued 14 days prior to the Baseline visit.

⁃ Child bearing potential: In addition, you must be willing to use a method of contraception during the study period and for 4 weeks after the last dose of study drug. (Note: Periodic abstinence calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable as abstinence.)

Locations
United States
Pennsylvania
Penn State Hershey Medical Center
RECRUITING
Hershey
Contact Information
Primary
Andrea Zaenglein, MD
azaenglein@pennstatehealth.psu.edu
717-531-1513
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2028-01
Participants
Target number of participants: 24
Treatments
Experimental: Open-label
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Related Therapeutic Areas
Sponsors
Collaborators: Incyte Corporation
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov